Jarina Plus Film-Coated Tablets

JARINA PLUS is a contraceptive pill and it is used to prevent pregnancy and to improve the folate status in women who decide to use oral contraception. Each of the 21 orange film-coated tablets contains a small amount of the female hormones ethinylestradiol and drospirenone and levomefolate calcium (which is also contained in the 7 light orange hormone-free film-coated tablets). Contraceptive pills that contain two hormones are called “combined pills” or “combined oral contraceptives”.

Do not use JARINA PLUS if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use JARINA PLUS. Your doctor may advise you to use a different type of pill or an entirely different (non-hormonal) method of birth control. Do not take JARINA PLUS:

• If you are allergic (hypersensitive) to ethinylestradiol, drospirenone, levomefolate calcium or any of the other ingredients in JARINA PLUS. This may cause, for example, itching, rash or swelling.
• If you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other parts of the body.
• If you have (or have ever had) a heart attack or stroke (caused by a blood clot or a rupture of a blood vessel in the brain).
• If you have (or have ever had) a disease that can be an indicator (i) of a future heart attack (for example, angina pectoris which causes severe chest pain which may spread to the left arm) or (ii) of a stroke (for example, a minor stroke with no residual effects, a so-called transient ischaemic attack).
• If you have a severe or multiple risk factor(s) for blood clots (see “The Pill and blood clots” and consult your doctor who will decide whether you may use JARINA PLUS).
• If you have (or have ever had) a certain kind of migraine (with so-called focal neurological symptoms such as visual symptoms, speech disability, or weakness or numbness in any part of your body).
• If you have diabetes mellitus with damaged blood vessels.
• If you have (or have ever had) liver disease (symptoms of which may be yellowing of the skin or itching over the whole body) and your liver is still not working normally.
• If you have (or have ever had) a cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs).
• If you have a severe kidney insufficiency or acute kidney failure.
• If you have (or have ever had) a benign or malignant tumour of the liver.
• If you have any unexplained bleeding from the vagina.
• If you are pregnant or think you might be pregnant.

Do not share medicines prescribed for you with others. The JARINA PLUS pack contains 28 tablets (21 hormone-containing orange tablets and 7 hormone-free light orange tablets). Take your tablet at about the same time each day, with some liquid if necessary. Follow the direction of the arrows until all 28 tablets have been taken. The first course of JARINA PLUS is started on the first day of the menstrual period (day 1 of the cycle) from the silver section of the pack by selecting the appropriate tablet for that day of the week (e.g. “MO” for Monday). Thereafter one tablet must be taken daily for 28 days following the direction shown by the arrows. It does not matter at what time of the day the tablet is taken, but once you have selected a particular time, the tablet should be taken as near as possible at the same time each day. Withdrawal bleeding usually starts on day 2 or 3 after starting the inactive tablets and may not have finished before the next pack is started. Each subsequent pack is started in the silver section the day after the last tablet of the current pack. When taken correctly, combined oral contraceptives have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.

Not all side effects reported for JARINA PLUS are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. Tell your doctor if you notice any side effect, especially if severe or persistent, or if there is a change in your health that you think might be caused by the Pill. JARINA PLUS can cause side effects. Serious side effects: See also section “Take special care with JARINA PLUS”, “JARINA PLUS and blood clots” and “JARINA PLUS and cancer” for side effects, including serious reactions, associated with the use of JARINA PLUS. Please read these sections carefully and consult your doctor at once where appropriate. The following side effects were reported in studies with Yasmin and are also regarded as being representative for JARINA PLUS: Frequent side effects: Depressive mood, headache, migraine, nausea, breast pain including breast tenderness, leukorrhoea (vaginal discharge), vaginal moniliasis (fungal infection), menstrual disorder, intermenstrual bleeding (bleeding irregularities usually subside during continued treatment). Less frequent side effects: Body weight changes, fluid retention, changes in interest in sex, high blood pressure, low blood pressure, vomiting, acne, eczema, itching, vaginitis (vaginal inflammation). Rare side effects: Hypacusia (hearing impairment), thromboembolism (blood clots including embolism), asthma, breast discharge. Other side effects that have been reported are: allergic reactions (hypersensitivity), altered mood, contact lens intolerance, abdominal pain, diarrhoea, rash, urticaria (hives), skin disorders such as erythema nodosum or multiforme, breast enlargement. If you have hereditary angioedema (swelling which involve lips, eyes or tongue) medicines containing certain female sex hormones (estrogens) may induce or worsen the symptoms of angioedema (see section “Take special care with JARINA PLUS”).

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN. Store at or below 30 °C. Keep the blister strip in the pouch, in the original carton until required for use. Do not use after the expiry date stated on the carton and the blister strip. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).